Timelines of translational science: From technology initiation to FDA approval
| Autor: | Michael J. Walsh, Fred D. Ledley, Laura M. McNamee |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Oncology Physiology lcsh:Medicine Gene Expression Growth control Pharmacology Biochemistry Translational Research Biomedical 0302 clinical medicine Immune Physiology Drug Discovery Drug approval Medicine and Health Sciences Morphogenesis Medicine lcsh:Science Drug Approval Multidisciplinary Immune System Proteins Organic Compounds Fda approval Gene Therapy Chemistry Drug development Physical Sciences Translational science Research Article Biotechnology medicine.medical_specialty Drug Research and Development Immunology Research and Analysis Methods Antibodies 03 medical and health sciences Internal medicine Genetics Humans Clinical Trials Protein translation Molecular Biology Techniques Molecular Biology Growth Control Clinical Genetics business.industry United States Food and Drug Administration lcsh:R Organic Chemistry Chemical Compounds Biology and Life Sciences Proteins Timeline United States Monoclonal Antibodies Clinical trial 030104 developmental biology Small Molecules lcsh:Q Protein Translation Clinical Medicine business 030217 neurology & neurosurgery Developmental Biology |
| Zdroj: | PLoS ONE PLoS ONE, Vol 12, Iss 5, p e0177371 (2017) |
| ISSN: | 1932-6203 |
| Popis: | While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve) maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p |
| Databáze: | OpenAIRE |
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